(164 days)
The Erchonia IOTO_240 is a galvanic generator that is indicated for use in tap water iontophoresis to treat palmer hyperhidrosis and plantar hyperhidrosis.
The Erchonia IOTO_240 is a galvanic generator.
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA regarding the "Erchonia IOTO 240" iontophoresis device. It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance.
However, the document does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, details of a multi-reader multi-case study, standalone algorithm performance, or ground truth establishment relevant to the questions you've asked.
The document primarily focuses on the regulatory approval process and states the intended indications for use, but it does not include the detailed technical and clinical study information you are seeking.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Erchonia Medical Inc. % Regulatory Insight, Inc. Mr. Kevin Walls RAC Principal Consultant 13 Red Fox Lane Littleton, Colorado 80127
MAR 0 1 2007
Re: K062792 Trade/Device Name: Erchonia Ioto 240 Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class III Product Code: EGJ Dated: 01/05/2007 Received: 01/11/2007
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation
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Page 2 - Mr. Kevin Walls RAC
(21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Erchonia IOTO 240
Indications for Use: The Erchonia IOTO_240 is a galvanic generator that is indicated for use in tap water iontophoresis to treat palmer hyperhidrosis and plantar hyperhidrosis.
Prescription Use × AND/OR ` (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH JOffice of Device Evaluation (ODE)
P
(Division Sign-Off) (Division of General, Re-Inrative, and Neurolegis
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510(k) Number
N/A